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Professor Di Renzo: I am a little bit puzzled by the fact, that in
fact, from some of these drugs there has been a lot literature published. This
is, somehow, a form of defence for the liable doctor in the sense that he can
say, “Okay, but this has been used in the general and scientific world and
apparently there are no harmful effects”. This can be a defence. I believe that
to prepare an informed consent to any patient and say, “We are going to use this
drug, which has no indication for that but has been used scientifically, instead
of the other”. Obviously the reasons are maybe that the hospital does not buy
this other drug. It is a little bit intriguing. Or you have to tell the patient,
“Okay, at this hospital we do not use this. If you want to have this drug you
have to move to another hospital”. What is your opinion about that?
Mr. Shah: Absolutely, I think it is a very, very difficult situation,
particularly where hospital administrations are actually not buying a particular
drug. The situation really is well, individual liability. The hospital can be
vicariously liable, but this is individual liability. How do you actually cover
yourself? Covering yourself is actually having an adequate consenting process,
and actually recording that in the medical records. Now I agree with you that
evidence and papers that come about with regards to safety, with regards to the
use of Nifedipine, adds to the evidence that can be submitted by experts at a
court hearing. But, on a case-by-case basis, it will really fall down to whether
adequate consent and valid consent, was achieved. The evidence can help to
satisfy a defence against a breach of duty for using nifedipine over atosiban.
But evidence itself will not necessarily be enough defence for the lack of
consent, of actually providing information that there is a licensed alternative
available, that this is an off-licence medicine and what it actually means
because it is open for the patient to actually claim that there was a failure to
inform.
Question: Regarding your last statement, in that case when we use
steroids for prematurity? they are not licensed anyway. So, do we need to
consent them for the use of steroids for prematurity?
Mr. Shah: Again, if there are no licensed alternatives available, when
you are using an off-label medicine in that particular case all the evidence
will help in your defence if there is a claim of harm caused by it. The case is
different when there are licensed alternatives available. I think that the
difficulty is when using an off-label medicine, how do you justify that using
the off-label medicine is better for the patient than a licensed alternative,
which has actually been tested for its use in preterm labour?
Question continues: Yes, I understand, but as you say when we do not have
alternatives, is it imperative for us to take consent?
Mr. Shah continues: If you do not have an alternative, explaining to the
patient that this is an off-label medicine, there are actually no alternatives
and this is my advice to you, I think will actually cover the consenting
process, if it is actually recorded in the notes that is fine. It is only when
there is a licensed alternative available that you are in difficulty.
Professor Di Renzo: By the way, in the case of steroids, you may be sued
because you did not give steroids for RDS, so it is the other way around. The
key issue is that you have an off-label and an alternative. For steroids there
are no alternatives. In any case now I am sure that anybody is not sued because
of giving steroids, but because of not giving steroids for enhancing
prematurity.
